Device Classification Name |
instrument, measuring, lens, ac-powered
|
510(k) Number |
K801767 |
Device Name |
DIMENSION I REFRACTION SYSTEM |
Applicant |
SMR |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
SMR |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 886.1425
|
Classification Product Code |
|
Date Received | 07/28/1980 |
Decision Date | 09/16/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|